NUBERT, ALBERT AND HUBERT IMPERVIOUS BAGS FOR ENDOSCOPIC RETRIEVAL OF TISSUE

K033842 · Vernon-Carus Limited · GCJ · Mar 4, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K033842
• Device Name: NUBERT, ALBERT AND HUBERT IMPERVIOUS BAGS FOR ENDOSCOPIC RETRIEVAL OF TISSUE
• Applicant: Vernon-Carus Limited
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Mar 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Nubert, Albert and Hubert impervious bags for endoscopic retrieval of tissue arc single-use disposable devices used as receptacles for the collection and extraction of tissue during laparoscopic surgical procedures. There are three sizes of impervious bags for the endoscopic retrieval of tissuc: NUBERT (a new bag for the endoscopic retrieval of tissue), ALBERT (a large bag for the endoscopic retrieval of tissue), and HUBERT (a huge bag for the endoscopic retrieval of tissue).

Device Story

Single-use disposable impervious bags designed for laparoscopic tissue retrieval. Device functions as a receptacle to contain tissue specimens during extraction from the abdominal cavity. Used in clinical settings by surgeons during laparoscopic procedures. Provides a barrier to prevent tissue contact with the port site or surrounding anatomy during removal. Benefits include simplified specimen retrieval and reduced risk of tissue contamination or seeding during extraction.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-use disposable impervious bags. Available in three sizes (Nubert, Albert, Hubert).

Indications for Use

Indicated for use as receptacles for the collection and extraction of tissue during laparoscopic surgical procedures in patients requiring such intervention.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Mtp Endobag® Disposable Extraction Bag (K990912)
• LiNA-Bag (K030422)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness for the Nubert, Albert and Hubert Impervious Bags is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(k) summary.

| Applicant: | Vernon-Carus Limited<br>Penwortham Mills<br>Preston, Lancashire PR1 9SN<br>United Kingdom |
|----------------------|-------------------------------------------------------------------------------------------|
| | Mr. Alan Davies<br>Group Regulatory Affairs Manager |
| | Contact Person: |
| Preparation Date: | 14 November 2003 |
| Device Trade Name: | Nubert, Albert and Hubert Impervious Bags for<br>the Endoscopic Retrieval of Tissue |
| Common Name: | Laparoscopic Specimen Retrieval Bag |
| Classification Name: | Laparoscopic, General and Plastic Surgery<br>21 CFR 876.1500 |

## Predicate Devices:

- Mtp Endobag® Disposable Extraction Bag (K990912); .
- LiNA-Bag (K030422) .

#### Device Description:

Single-use disposable device used as a receptacle for the collection and extraction of tissue during laparoscopic surgical procedures.

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K035842 2/2

### Intended Use of the Device:

The Nubert, Albert and Hubert impervious bags for endoscopic retrieval of tissue arc single-use disposable devices used as receptacles for the collection and extraction of tissue during laparoscopic surgical procedures. There are three sizes of impervious bags for the endoscopic retrieval of tissuc: NUBERT (a new bag for the endoscopic retrieval of tissue), ALBERT (a large bag for the endoscopic retrieval of tissue), and HUBERT (a huge bag for the endoscopic retrieval of tissue).

## Substantial Equivalence to Predicate Devices:

The Nubert, Albert and Hubert Impervious Bags for the Endoscopic Retrieval of Tissue are substantially equivalent in design and materials to the listed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo in the center. The logo is a stylized depiction of an eagle with three horizontal lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 4. 2004

Vernon-Carus Limited c/o Mr. C. Robert Payne, Jr., P.E. CRP Enterprises P.O. Box 2608 Morgan Hill, California 95038

Re: K033842 Trade/Device Name: Nubert, Albert and Hubcrt Impervious Bags for the Endoscopic Retrieval of Tissue Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: November 14, 2003 Received: December 10, 2003

Dear Mr. Payne:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your booten or (2) the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use nated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered provided in accordance with the provisions of the Federal Food, Drug, ue vices that have been require approval of a premarket approval application (PMA). and Cosmotion For (110) that the device, subject to the general controls provisions of the Act. The I ou may, disrettle, mains of the Act include requirements for annual registration, listing of general controlly provider ing practice, labeling, and prohibitions against misbranding and adultcration.

If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it rr your device is elassinod (tional controls. Existing major regulations affecting your device can may be subject to Sach assisted Regulations, Title 21, Parts 800 to 898. In addition, FDA may oc round in the Outsernents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that I Dri which that your device complies with other requirements of the Act that I DA has Inade a determinations administered by other Federal agencies. You must of any i cutar statures and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Crith in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic fordiner me quality by court of Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. C. Robert Payne, Jr., P.E.

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin maxing of substantial equivalence of your device to a legally premarket notincation: "The PDF mailing sification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acrite for Joan as 1) 594-4659. Also, please note the regulation entitled, Connact the Office of Comptimation" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Ericlosure

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#### INDICATIONS FOR USE

510(k) Number: K033842

Nubert, Albert and Hubert Impervious Bags for the Endoscopic Device Name: Retrieval of Tissue

Indications for Use:

The family of impervious bags for endoscopic retrieval of tissue are single-use The family of importantes for the collection and extraction and extraction of tissue during laparoscopic surgical procedures. The family includes three sizes of impervious bags for the endoscopic retrieval of tissue: NUBERT (a new bag for the endoscopic retrieval of tissue), ALBERT (a large bag for the endoscopic retrieval of tissue), and HUBERT (a huge bag for the endoscopic retrieval of tissue).

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line -- Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

Division of General, Restorative, and Neurological Devices

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**510(k) Number** K033842